Regulatory Compliance Services
Effectively resolving complex regulatory issues
Global industry leader in regulatory and compliance services
Flavine is proud to offer comprehensive regulatory services that are catered to your unique needs. As your preferred regulatory agent, we will work closely with you to effectively resolve regulatory issues and help simplify the drug approval process within the United States, Europe, China, India, Middle East and North Africa. Our teams of regulatory experts have decades worth of expertise working with health authorities such as the US FDA, EDQM, and CFDA. We understand how to successfully navigate the various regulatory landscapes and assist you with your regulatory and compliance requirements.

Full range of regulatory services
Our state of the art, GMP-compliant laboratory facility in Vitrolles, France offers comprehensive analytical services, QC retest, and release testing of APIs and FDFs according to your specifications or compendial. Complementing our full-service QC testing, we also provide robust method development, validation, and transfer of pharmaceuticals and raw materials.
Regulatory Compliance
- GDUFA Facility Self-identification filing and annual updates
- Establishment Registration SPL filing and annual updates
- cGMP audits and remediation plans
- On-site support for national and international regulatory authority audits
- Inspection observation responses and CAPAs
- Initiate GMP facility inspection for European Union
Labeling
- Review of labeling to comply with regulatory standards and customs clearance requirements
- NDC Labeler Code SPL filing
- NDC Product Listings SPL filing and routine updates
Master File and Dossier Preparation
- Compile and prepare electronic files in eCTD format in support of master files (DMF, VMF, and EDMF/ASMF) as well as CEP/COS
- Preparation and filing of FDF dossier
- Represent API manufacturer during interactions with regulatory authorities
- Submit files electronically through established gateways
- Provide technical assistance with deficiency responses
- Assist with lifecycle management including amendments, annual reports, LOAs, etc.
- Offer full comprehensive services for Chinese Drug Master File (DMF) registration and maintenance